Casdatifan

HAYWARD, Calif.--(BUSINESS WIRE)--Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for the treatment of cancer and inflammatory diseases, announced today that it will host an in-person investor event with a live webcast on Tuesday, October 20, 2026, beginning at 8:30 AM ET, in New York City. The event will highlight new data from the ARC-20 platform study, which is evaluating casdatifan, a next-generation HIF-2α inhibitor, alone or in combination, as a first-, second- and late-line treatment for clear cell renal cell carcinoma (ccRCC). Featured presenters will include members of the Arcus management team and Dr. Rana McKay, Professor of Medicine and Urology at the University of California San Diego, who is a leading academic expert in the treatment of kidney cancer with deep experience using HIF-2α inhibitors. New data to be presented will include: First-line TKI-free combinations: Casdatifan plus zimberelimab (anti-PD-1 antibody ): Data will include safety and early efficacy, including rate of primary progression, overall response rate (ORR), and progression-free survival (PFS) for 30 patients with a median follow-up of approximately 11 months. Casdatifan plus ipilimumab plus zimberelimab: Data will include safety and rate of primary progression for approximately 20 patients. Safety data from this cohort will support initiation of the first-line registrational trial PEAK-20, evaluating casdatifan plus ipilimumab plus nivolumab, expected to occur in the fourth quarter of 2026. Second-line TKI-containing combination: Casdatifan plus cabozantinib: Efficacy data will include ORR, PFS, and early overall survival (OS) for 43 patients with a minimum of 18 months and a median of approximately 21 months of follow-up and a subgroup analysis of efficacy (including PFS and OS) based on prior therapy. Safety and tolerability data will also be provided for this cohort. This is the same combination and patient population being evaluated in the registrational trial PEAK-1, expected to be fully enrolled at the end of 2026. Late-line monotherapy: Casdatifan monotherapy: Data will include OS, as well as updated ORR and PFS, for 121 patients in the pooled monotherapy cohorts, with median follow-up of approximately 28 months. Arcus will also be highlighting new subgroup analyses, including evaluation of casdatifan monotherapy efficacy for both PFS and OS by prior therapy. In addition, Arcus will share the first translational data correlating pharmacodynamic markers of HIF-2α inhibition with overall survival. The presentation will also include market opportunity and review of Arcus's development strategy, which is designed to generate evidence to secure casdatifan as a backbone therapy in ccRCC so that every patient has the opportunity to benefit from casdatifan across each line of therapy over the course of their care. Please contact Arcus Investor Relations regarding in-person attendance. The event will be broadcast live via webcast here: . A replay will be available following the live event in the “Investors & Media” section of the Arcus Biosciences website at . About Casdatifan (AB521) Casdatifan is a small-molecule inhibitor of hypoxia-inducible factor 2-alpha (HIF-2a), a master switch that turns on hundreds of genes in response to low oxygen levels. In a majority of people with the most common form of kidney cancer (clear cell renal cell carcinoma), genetic anomalies result in the dysregulation of this master switch and transformation of normal kidney cells into cancerous ones. Casdatifan was designed to provide deep and durable inhibition of the HIF-2a pathway. Early clinical studies have shown high response rates and a low primary progression rate relative to clinical benchmarks, warranting further investigation in late-stage studies. Casdatifan, which is administered in pill form once daily, has a safety pro allows it to be investigated in combination with other treatments. The casdatifan development strategy is designed to generate evidence needed to establish casdatifan as a backbone therapy so that every ccRCC patient has the opportunity to benefit from casdatifan across each line of therapy. In addition to partner-operationalized studies, including combinations with casdatifan and anti-PD-X/VEGF bispecifics, Arcus is investigating casdatifan across multiple cohorts in the ARC-20 platform study, alone and in combination with other potential new treatment options, including in: The first-line setting with cohorts evaluating casdatifan plus zimberelimab, an anti-PD-1 (ongoing); casdatifan plus zimberelimab and ipilimumab, an anti-CTLA-4 (ongoing); and casdatifan plus ivonescimab, an anti-PD-1/VEGF bispecific (planned) The second-line setting with a cohort evaluating casdatifan plus cabozantinib, a TKI, in immunotherapy-experienced patients (ongoing) The late-line setting with a cohort evaluating casdatifan plus tivozanib, a TKI, in HIF-2a inhibitor-experienced patients (planned) Arcus is also enrolling PEAK-1, the global Phase 3 study evaluating casdatifan plus cabozantinib versus cabozantinib in immunotherapy-experienced patients with metastatic ccRCC. Arcus expects to complete enrollment in PEAK-1 and to initiate the Phase 3 PEAK-20 study in first-line metastatic ccRCC by year-end 2026. Casdatifan is an investigational molecule. Approval from any regulatory authority for its use has not been received, and its safety and efficacy have not been established. Taiho has development and commercial rights in Japan and other countries in Asia, excluding China. Arcus Biosciences holds full rights to casdatifan everywhere else globally. About Arcus Biosciences Arcus Biosciences is a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules for the treatment of cancer and inflammatory diseases. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of its late-stage portfolio of first- and/or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has advanced multiple investigational medicines into registrational clinical trials including casdatifan, a HIF-2α inhibitor for clear cell renal cell carcinoma, and quemliclustat, a small-molecule CD73 inhibitor for pancreatic cancer. For more information about Arcus Biosciences’ clinical and preclinical programs, please visit . Forward-Looking Statements This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Arcus’s expectations for the content of the investor presentation and the timing and achievement of milestones, including the completion of PEAK-1 and the initiation of PEAK-20. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause Arcus’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, risks associated with: difficulties or delays in initiating, enrolling and completing clinical trials, including due to regulatory review, site activation, patient identification or enrollment, or manufacturing and supply constraints of investigational or standard-of-care products for such clinical trials; changes in the competitive landscape for Arcus’s programs; and the inherent uncertainty associated with pharmaceutical product development and clinical trials. Risks and uncertainties facing Arcus are described more fully in the “Risk Factors” section of Arcus’s most recent periodic report filed with the U.S. Securities and Exchange Commission (SEC) and in other filings that Arcus makes with the SEC from time to time, which are available at . You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release, except to the extent required by law. Contacts Investor Inquiries Pia Eaves VP of Investor Relations & Strategy (617) 459-2006 peaves@arcusbio.com Media Inquiries Holli Kolkey VP of Corporate Affairs (650) 922-1269 hkolkey@arcusbio.com Maryam Bassiri Director, Corporate Affairs (510) 406-8520 mbassiri@arcusbio.com

盈德健康(lndian-Med)是少数获得印度政府授权的印度本土正规跨境药房。盈德健康属于印度最大的医药供应链集团Medikabazaar，全球员工超1500人，全印度各地设有42个分公司。盈德健康为病友们提供印度老挝孟加拉等多国仿制药和原研药合法跨境购买服务，所有药品均可提供印度源头采购文件，杜绝假药风险。盈德健康所有药品均通过印度药监局(CDSCO)认证，支持处方审核+跨境直邮，确保患者安全用药。中国人保产品责任险承保盈德健康跨境药房全线产品，央企为您的药品质量做全面保障，盈德健康药品质量值得信赖!①联系邮箱：china01@indianmed.cn ②联系方式：19926578359 ③微信号:IDM2026 默沙东与卫材公布的III期LITESPARK-012研究未达主要终点。在晚期肾透明细胞癌一线治疗中，贝组替凡加入帕博利珠单抗联合仑伐替尼后，无进展生存期和总生存期均未见改善。 1. 贝组替凡的作用机制与获批信息 2. KEYMAKER-U03与LITESPARK-012结果对比 3. 联合治疗未能增益的可能原因 4. 对后续肾癌药物研发的启示 5. 热门用户问答 6. 总结 01 一、研究结果：三联方案未改善生存 贝组替凡是全球首个HIF-2α抑制剂。它可选择性阻断HIF-2α与HIF-1β形成转录复合体，抑制VHL-HIF通路下游VEGF等促血管生成基因表达，从而减少缺氧环境下的血管生成和肿瘤细胞增殖。 在难治性肾癌二线治疗及早期肾癌辅助治疗研究中，贝组替凡曾取得积极结果。基于这些数据，默沙东与卫材进一步探索其在晚期肾透明细胞癌一线治疗中的价值。 LITESPARK-012研究结果没有达到预期。研究比较了两种联合方案与帕博利珠单抗联合仑伐替尼方案，结果显示，贝组替凡三联方案以及MK-1308A联合仑伐替尼方案，均未达到无进展生存期和总生存期双主要终点。 研究对象为晚期肾细胞癌一线治疗患者。第一种试验方案由帕博利珠单抗、仑伐替尼和贝组替凡组成；另一种方案使用MK-1308A，即帕博利珠单抗与在研抗CTLA-4抗体quavonlimab组成的复方制剂，再联合仑伐替尼。 从安全性看，联合方案总体表现与既往单药研究，以及帕博利珠单抗联合仑伐替尼方案的安全性特征基本一致。现有信息未显示新增明显不同的安全性信号。 02 二、贝组替凡基础信息 贝组替凡于2021年首次获得FDA批准。最初适应证为治疗VHL病。2023年底，该药进入肾癌治疗领域；2025年全球销售额为7.16亿美元，同比增长41%。 2024年11月，国家药品监督管理局批准贝组替凡片上市，批准文号为国药准字HJ20240135。药品适用于不需要立即接受手术的成人VHL病患者。 具体适用疾病包括VHL病相关肾细胞癌、中枢神经系统血管母细胞瘤，以及胰腺神经内分泌肿瘤。实际用药仍应依据获批说明书和医生评估。 贝组替凡基础信息来源：Pharma ONE药物研发大数据平台、中国医药工业信息中心。 03 三、早期数据曾带来较高期待 在2025年ESMO大会公布的KEYMAKER-U03研究子研究03A中，贝组替凡、帕博利珠单抗与仑伐替尼三联方案显示出较高缓解率。该研究属于伞式研究，用于评估多种帕博利珠单抗三联治疗方案。 该三联方案客观缓解率为78%，完全缓解率为12.5%。研究报告的中位无进展生存期为31.8个月，对照组为26.3个月；疾病进展或死亡风险下降55%，风险比HR为0.45。 这些结果一度让泌尿肿瘤领域对HIF-2α抑制剂的一线应用产生较高期待。研究者希望通过同时作用于缺氧信号、免疫检查点和血管生成通路，进一步提高治疗效果。 但早期研究的积极信号并未在III期LITESPARK-012中得到验证。III期研究纳入患者数量更多，随访时间更长，结果通常更能反映方案在广泛患者群体中的实际表现。 04 四、联合治疗中的“加法陷阱” 不同靶点同时用药，并不意味着疗效一定相加。联合方案可能受到毒性累积、药物相互影响和患者生物学差异的影响，最终收益未必达到预设水平。 在VHL综合征相关肾癌中，贝组替凡已经改变了这一罕见病的治疗方式。散发性肾透明细胞癌同样常见VHL基因失活，并伴随HIF信号累积，因此HIF-2α通路具有研究价值。 然而，散发性肾癌患者的肿瘤生物学差异更大。并非所有患者都能从HIF-2α抑制中获得相同程度的收益，单一通路的抑制效果也可能受到既有治疗和耐药机制影响。 肾癌一线治疗的疗效基础已经明显提高。当前PD-1联合TKI方案的中位无进展生存期约为20至24个月，总生存期超过50个月；舒尼替尼时代的中位无进展生存期约为8至11个月。 在现有标准治疗已经取得较好疗效的情况下，新药要在统计学上显示优势，必须带来持续且幅度足够的真实获益。若增益较小，长期随访后可能难以与对照方案拉开差距。 LITESPARK-012共纳入1688例患者。样本量扩大后，患者之间的疾病特征和既往情况差异也会增加。早期研究中的优势如果只存在于部分亚组，放入更广泛的人群后可能被整体结果削弱。 因此，KEYMAKER-U03中观察到的无进展生存期优势，未能在LITESPARK-012中转化为统计学显著的整体获益。这种结果提示，早期信号需要经过充分验证，不能直接等同于确切临床获益。 05 五、对默沙东与卫材的影响 对卫材而言，仑伐替尼联合帕博利珠单抗已经是晚期肾透明细胞癌一线治疗的重要方案。三联方案未能改善主要终点，反而使现有双联方案的临床地位更加稳定。 对默沙东而言，贝组替凡原本被寄予扩大肾癌适应证和销售规模的期待。LITESPARK-012失利后，它更可能继续作为特定患者或特定治疗阶段的重要补充，而不是普遍替代现有一线标准。 默沙东表示，LITESPARK-012未达终点不会影响贝组替凡在其他LITESPARK项目中的开发，包括与卫材合作开展的研究。基于LITESPARK-011二线适应证提交的申请，目前仍在接受FDA审评。 这项结果也为正在开发HIF-2α抑制剂的企业提供了参考。Arcus及其候选药物casdatifan在推进相关研究时，需要更加重视患者筛选、联合方案设计和长期获益评估。 06 六、研发重点或从“加法”转向精准分层 肿瘤药物开发不能只依靠不断增加治疗强度。当PD-1与TKI已经建立较高疗效基础后，继续叠加药物需要明确回答一个问题：哪些患者能够获得额外收益。 如果缺少可靠的生物标志物，所有患者都接受强化治疗，部分人可能只增加不良反应，却没有获得相应疗效。精准识别获益人群，有助于减少不必要的治疗负担。 对临床实践而言，LITESPARK-012并不否定贝组替凡在VHL病相关肿瘤及其他研究方向中的价值。它说明的是，某一药物在特定疾病中的成功，不能直接推导出其在另一治疗线次中的联合方案同样有效。 ▍扫码咨询专业顾问 | 在线一对一精准解读检查报告，同步海外药品前沿动态 07 七、热门用户问答贝组替凡是什么药？ 贝组替凡是HIF-2α抑制剂，可阻断HIF-2α相关信号。该药已获批用于VHL病相关肾细胞癌、中枢神经系统血管母细胞瘤和胰腺神经内分泌肿瘤等适应证。LITESPARK-012研究得出了什么结果？ 研究评估了贝组替凡三联方案及MK-1308A联合仑伐替尼方案。两种方案与帕博利珠单抗联合仑伐替尼相比，均未达到无进展生存期和总生存期双主要终点。贝组替凡三联方案还能继续研究吗？ 可以。默沙东表示，LITESPARK-012未达终点不会影响其他LITESPARK项目的开发。不同研究的患者人群、治疗阶段和方案设计并不相同，结果需要分别判断。研究失败是否意味着贝组替凡无效？ 不是。贝组替凡在VHL病相关肿瘤等领域已有获批适应证或研究依据。此次结果主要说明，在晚期肾透明细胞癌一线治疗中，将其加入帕博利珠单抗联合仑伐替尼未显示额外生存获益。患者是否应自行调整肾癌治疗方案？ 不应自行停药、换药或增加联合用药。肾癌治疗需要结合病理类型、分期、既往治疗、身体状况和药品说明书，由专业医生制定方案。 08 八、总结 LITESPARK-012未能证明贝组替凡加入帕博利珠单抗联合仑伐替尼可以改善晚期肾透明细胞癌一线治疗结局。这项研究提醒我们，早期研究中的积极信号必须经过大型III期试验验证，联合用药也需要以明确的患者获益为基础。 本文仅供健康科普参考，不构成诊疗或用药建议；具体治疗与用药请遵循医生指导。 09 九、资料参考 《Belzutifan for Renal Cell Carcinoma in von Hippel-Lindau Disease》；New England Journal of Medicine；2021年。 《Welireg（belzutifan）Prescribing Information》；美国食品药品监督管理局FDA官方文件；2021年。 《贝组替凡片上市批准信息（国药准字HJ20240135）》；国家药品监督管理局NMPA官方信息；2024年11月。 《KEYMAKER-U03研究子研究03A：贝组替凡联合帕博利珠单抗及仑伐替尼治疗晚期肾细胞癌》；欧洲肿瘤内科学会ESMO大会摘要；2025年。 《LITESPARK-012研究结果公告》；默沙东官方研究信息；发布时间以公司公告为准。 声明：本文内容仅为科普，不构成任何医疗建议。具体用药方案请以主治医生的诊断为准。购买仿制药需通过正规渠道，避免购买来源不明的药品。▍跨境购买印度抗癌药，添加客服交流，获取更多健康信息--盈德健康是印度本土最大的持牌线上跨境药房 * 本文所涉及药械建议通过合法跨境贸易方式凭处方购买* 个体治疗效果存在差异，用药需遵医嘱，本文药械信息，仅供参考，不构成用药指引.* 资料来源：药品说明书. #印度仿制药在哪买#靶向药血压升高处理#老挝抗癌药可信吗 点击下方阅读原文直接进入盈德健康印度线上药房获取你需要的印度药品更多药品相关问题，欢迎评论区留言讨论